NCT07395960 · Phase 1 · RECRUITING
The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment
This trial is testing whether metformin, a common diabetes drug, can slow or reduce mild cognitive impairment in older adults who are overweight or obese. Researchers will compare metformin plus lifestyle changes against lifestyle changes alone, using brain scans and a standard cognitive scale over 26 weeks. This is a Phase 1 trial — focused primarily on safety, with a small group of 54 participants, so results will be early and exploratory.
Inclusion criteria
- Age: 60 - 75 years old
- Body Mass Index: ≥ 24 kg/m2
- Glycated Hemoglobin \< 8.5%
- Moca Scale score: 20-26 points (education> 10 years) or 20-25 points (education≤ 10 years)
- Sign the informed consent form
Exclusion criteria
- Any hypoglycemic drugs have been used within 8 weeks prior to enrollment
- Type 1 diabetes
- Unable to undergo central nervous system magnetic resonance examination
- History of alcohol or drug addiction
- Severe gastrointestinal diseases, history of gastrointestinal surgery, severe cardiac or pulmonary dysfunction, malignant tumors and other diseases
- Abnormal liver function (liver enzyme indicators more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate\< 45 ml/min)
- There are diseases such as cerebral infarction and vascular dementia
- There are conditions judged by the investigator as being unsuitable for enrollment
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-09